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The investigators are conducting a 16 week multiple cross-over study (N-of-1 trial) comparing two blenderized tube feeds varying in viscosity in 40 children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extremely Thick - Mildly Thick - Extremely Thick - Mildly Thick | Experimental | Participants will receive 4 weeks Extremely Thick, 4 weeks Mildly Thick, 4 weeks Extremely Thick and 4 weeks Mildly Thick blenderized tube feeds. The volume, caloric density and frequency will be matched to pre-study feeding regimen. |
|
| Extremely Thick - Mildly Thick - Mildly Thick - Extremely Thick | Experimental | Participants will receive 4 weeks Extremely Thick, 4 weeks Mildly Thick, 4 weeks Mildly Thick and 4 weeks Extremely Thick blenderized tube feeds. The volume, caloric density and frequency will be matched to pre-study feeding regimen. |
|
| Mildly Thick - Extremely Thick - Extremely Thick - Mildly Thick | Experimental | Participants will receive 4 weeks Mildly Thick, 4 weeks Extremely Thick, 4 weeks Extremely Thick and 4 weeks Mildly Thick blenderized tube feeds. The volume, caloric density and frequency will be matched to pre-study feeding regimen. |
|
| Mildly Thick - Extremely Thick - Mildly Thick - Extremely Thick | Experimental | Participants will receive 4 weeks Mildly Thick, 4 weeks Extremely Thick, 4 weeks Mildly Thick and 4 weeks Extremely Thick blenderized tube feeds. The volume, caloric density and frequency will be matched to pre-study feeding regimen. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extremely thick blenderized tube feed | Other | Commercial blenderized tube feed, not diluted |
|
| Measure | Description | Time Frame |
|---|---|---|
| Upper GI symptoms | differences in daily parental rating of upper gastrointestinal symptoms from the validated Gastroparesis Cardinal Symptom Index-Daily Diary (GCSI-DD) between extremely and mildly thick blenderized tube feeds | 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design) |
| Measure | Description | Time Frame |
|---|---|---|
| Gastrointestinal symptoms | Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptoms Questionnaire, scale of 0 to 100, higher scores indicate less symptom burden | 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design) |
| Gastrointestinal symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
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| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
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|
| Mildly thick blenderized tube feed | Other | Commercial blenderized tube feed, diluted with ingredients contained in blend |
|
Pediatric Quality of Life Inventory Gastroparesis Questionnaire, , scale of 0 to 100, higher scores indicate less symptom burden |
| 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design) |
| Pulmonary symptoms | Pediatric Cough Questionnaire, score ranges from 0 to 25, higher scores indicate less symptom burden | 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design) |
| Health care utilization | frequency of hospital admissions | 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design) |
| Health care utilization | length of hospital admissions | 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design) |
| Health care utilization | rates of ER/urgent care visits | 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design) |
| GI medication use | % of participants requiring acid suppressive medication or GI motility agents such as cyproheptadine and erythromycin | 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design) |
| Height | height | 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design) |
| Weight | Weight or weight for length | 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design) |
| Weight for height/body mass index (BMI) | weight for height (children < 2) or BMI (over 2 years of age) | 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design) |
| number of patients with unplanned G-tube exchange | 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design) |
| urine output adequacy | frequency of urine output | 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design) |
| rate of respiratory suctioning per day | how often suctioning is required (e.g. number of times per day) | 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design) |
| need for antibiotics for pneumonitis | frequency of antibiotics prescribed for pulmonary indications | 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design) |